1.Date of occurrence of the event:2016/06/05
2.Company name: OBI Pharma, Inc.
3.Relationship to the Company (please enter ”head office” or ”affiliatecompany”): The Company head office
4.Reciprocal shareholding ratios: N/A
5.Name of mass media: N/A
6.Content reported: N/A
7.Cause of occurrence: The description of the press conference held in Taipei exchange at 10:30 am, today (6/5):
Taiwan OBIPharma (4174) today (5) announced that the company’s research and development of new drugs OBI-822 / OBI-821for breast cancer (the OPT-822 / OPT-821 before), was presented at the annual meeting of 2016 ASCO held in Chicago, America in the form of an oral presentation (Abstract No. 1003) at the local time 14:15 pm of 6/4. This Active immunotherapy is used for metastatic breast cancer patients in clinical benefits and the Phase II/III research data of immunogenicity. The study showed that, for patients suffering from advanced metastatic breast cancer, they did not meet the primary efficacy endpoint of progression-free survival (PFS), but compared to patients receiving placebo, about 50% of patient population who can produce significant immunity to the immune therapy, their PFS will be significantly and visibly improved. As for the secondary efficacy endpoint of the study, overall survival (OS), the current data are immature.
Hope S. Rugo, MD, Breast Cancer Clinical Trials and Medical Education Officer of Helen Diller Family Comprehensive Cancer Center in University of California, San Francisco, also a research physician of this clinical trial, presented in his oral report, ‘for this innovative and active immunotherapy used for patients with metastatic breast cancer, the current data has revealed the clinical benefit of OBI-822/OBI-821, and we will take the test data as the base of the further design of Phase III clinical trial and find out the patient populations benefiting from this immunotherapy.
About PhaseII/ Phase III clinical trials
This study is a multinational, multi-center, randomized, double-blind, placebo-controlled clinical trial of Phase II/ Phase III (NCT01516307), during the course of treatment for 41 weeks, administered nine OBI-822 / OBI-821 injections or placebo , starting from the randomization, tracking the longest two-yearprogression-free survival (PFS) as well as the longest five- year overall survival (OS). There are total 348 patients in this test with the intention of treatment who had previously received metastatic breast cancer treatment of phase one to two and showed stable disease or response, and they were randomized (experimental group and the placebo group in a 2: 1 mode) to acceptsubcutaneous injection of OBI-822(30 micrograms Globo H-KLH) / OBI-821 (100 micrograms) or placebo and received low-dose intravenous cyclophosphamide in combination (cyclophosphamide, 300 mg / m2). The test experimental group and the placebo group were using hormone therapy and are approved beforehand. For the total 348 patients, there are 70% of patients with hormone receptor-positive breast cancer, 13% of triple-negative breast cancer, and 62% receiving hormonal therapy. The primary efficacy endpoint was observed the difference of the PFS (HR, 0.96 [95% CI, 0.74-1.25] P = .77) or interim OS (HR, 0.79 [95% CI, 0.51-1.22] P = .29)
However, 50% of patients during treatment had developed the Globo H specific IgG response to OBI-822 / OBI 821 with the antibody titers of 1: 160; compared with the placebo group, the patients receiving vaccine (in PFS , HR, 0.71 [95% CI, 0.52-0.97] P = .029; in OS, HR, 0.57 [95% CI, 0.33-0.97] P = .04), and the patients not generating an immune response (in PFS, HR, 0.51 [95% CI, 0.37-0.70] P <.0001; in OS, HR, 0.52 [95% CI, 0.29-0.92] P = .025) (the results had been corrected according to based disease status / hormone therapy), these patients were improved in PFS and OS in the mid-term trend.
In the Cox model for time dependent, with respect to progression-free survival (PFS), compared with the placebo group, the patients accepting all ninth injection of OBI822 / 821 also have a trend of improvement (HR, 0.66 [95% CI, 0.42- 1.01] P = .057).Generally speaking, the patients in the study period was well tolerated for this therapy, the main side effects from the vaccine include mild fever and local injection reactions.
About OBI-822 and OBI-821
OBI-822 is a developing, innovative and active cancer immunotherapy. It is the synthetic glycoprotein which is a covalently bound by Globo H, the tumor-associated carbohydrate antigens (TACA) and KLH. OBI-821 is a Sapon in adjuvant. Globo H has a high level of performance on many surfaces of epithelial malignancies, such as breast cancer, prostate cancer, stomach cancer, lung cancer, colon cancer, pancreatic cancer and ovarian cancer. When the Globo H combines with KLH to form OBI-822 (Globo H-KLH), and is treated with OBI-821 together, it can enhance the immunogenicity of the antigen. OBI-822 is exclusively authorized to to OBIPharma by Memorial Sloan-Kettering Cancer Center (MSKCC).
About Taiwan OBI Pharma
OBI Pharma was founded in 2002. It takes research and development of new drugs as self-positioning, and commits to challenge the current unsatisfied medical needs, and lock the two major areas of cancer and anti-infection. The company’s main products are innovative metastatic breast cancer active immunotherapy OBI-822; meanwhile, OBI Pharma is developing the next generation of active immunotherapy for refractory cancer as well with the applicable targets including lung cancer, prostate cancer, pancreatic cancer, stomach cancer and ovarian cancer. For additional information, please refer to the following URL:www.obipharma.com/en.
8.Countermeasures: None
9.Any other matters that need to be specified: Other matters shall state: The results of a single clinical trial are not enough to fully reflect the success or failure of future development of new drugs listed, and the investors should carefully make the judgement and be prudent in their investment.